MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; TRANSDUCER, BLOOD PRESSURE

Catalog Number H7498060100121

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

The device from the reported event has been returned to angiodynamics, however the device evaluation has not yet been concluded.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).

Event Description

As reported by angiodynamics' distributor in (b)(6), " it was reported that there was a manifold today that kept entraining air.Both the scrub nurse and the consultant checked the manifold connections and were unable to find where it was entraining from.There was no reported patient injury".The used device has been returned to angiodynamics for evaluation.

Manufacturer Narrative

A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the perceptor dts and manifolds product family and the failure mode "device air bubbles." no adverse trend was indicated.As received, the 3v manifold was returned with what appeared to be bio material {blood} inside and out.A visual inspection upon receipt was performed.It was noted during the visual inspection that a piece of the o-ring was broken.A visual inspection was performed on the rotating adaptor (ra), and confirmed a piece of the o-ring was missing from the o-ring in the stem cup.The reported complaint description was confirmed for rotating adaptor (ra) leaking air.The root cause of the air leak was a result of a broken/damaged o-ring in the rotating adaptor assembly on the manifold.The o-ring and rotating adaptor are manually assembled.Damage to the o-ring can occur during assembly if the o-ring is not placed flat in the bottom of the manifold stem cup.In addition, this connection is 100% visualized by the operator after the ra is swaged onto the manifold.The root cause for the broken o-ring is operator error during the assembly process and not identifying the non-conforming part during the visual inspection.The operators responsible for performing the process as outlined in angiodynamics assembly procedures for this device are no longer employed by angiodynamics.A full departmental re-training was performed recently for similar issues to raise awareness.Quality is tracked and reported daily in departmental meetings.These complaints were reviewed with all employees that currently perform these procedures with emphasis being placed on what can happen if our procedures are not followed.(pr19822).

• Brand Name: ANGIODYNAMICS
• Type of Device: TRANSDUCER, BLOOD PRESSURE
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7673692
• MDR Text Key: 113542457
• Report Number: 1317056-2018-00132
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: H7498060100121
• UDI-Public: H7498060100121
• Combination Product (y/n): N
• PMA/PMN Number: K951722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2020
• Device Catalogue Number: H7498060100121
• Device Lot Number: 5225259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1